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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cytochrome p450 2c9 (cyp450 2c9) drug metabolizing enzyme genotyping system
510(k) Number K073720
Device Name ESENSOR WARFARIN SENSITIVITY AND XT-8 INSTRUMENT
Applicant
OSMETECH MOLECULAR DIAGNOSTICS
757 SOUTH RAYMOND AVE.
pasadena,  CA  91105
Applicant Contact robert dicheck
Correspondent
OSMETECH MOLECULAR DIAGNOSTICS
757 SOUTH RAYMOND AVE.
pasadena,  CA  91105
Correspondent Contact robert dicheck
Regulation Number862.3360
Classification Product Code
ODW  
Subsequent Product Codes
NSU   ODV  
Date Received12/31/2007
Decision Date 07/17/2008
Decision substantially equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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